MAUDE Adverse Event Report: SUPERDIMENSION INC. SUPERDIMENSION INREACH BRONCHUS SYSTEM; ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY

Model Number AAS00161-12

Device Problems Unintended Movement (3026); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2015

Event Type  Injury  

Event Description

The patient suffered a pneumothorax during a superdimension procedure.It is unknown if the patient was hospitalized or required treatment at time of event.If additional information pertinent to the incident is obtained a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).A component of the superdimension system, case recordings, has been received and is under evaluation.When the evaluation is complete a follow-up report will be submitted.There were no anomalies identified during the internal review of the dhr of the system console.Pneumothorax is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.If additional information is received a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).Date of initial report : 06/02/2014.Date of follow-up report : 06/19/2014.A site service visit was completed and a component of the superdimension system, the location board (lb), was found to be cracked.The system was evaluated with the damaged lb and passed all accuracy and functional testing.The damaged lb was replaced and returned for further evaluation.Accuracy and functional testing of the system was performed with the new lb and met specification.Subsequent testing of the returned lb was performed at superdimension.Although visual damage to the lb was verified it did not affect the accuracy of the system, proven via three accuracy tests.A component of the superdimension system; case recordings, were returned and evaluated.The evaluation showed ct-to-body divergence however the cause of the ct to body divergence is unknown therefore no conclusion could be made.If additional information pertinent to the incident is obtained another follow-up report will be submitted.

• Brand Name: SUPERDIMENSION INREACH BRONCHUS SYSTEM
• Type of Device: ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY
• Manufacturer (Section D): SUPERDIMENSION INC.; 161 cheshire lane; suite 100; minneapolis MN 55441
• Manufacturer Contact: sharon murphy ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 4812725
• MDR Text Key: 5923495
• Report Number: 3004962788-2015-00035
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AAS00161-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 06/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other